ModeX Therapeutics Inc., an OPKO Health, Inc. company (NASDAQ: OPK), has been awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services (HHS), to advance a platform and specific candidates designed to address a range of public health threats in viral infectious diseases.
The awarded funding will enable research, development and clinical evaluation of potent multispecific antibodies, based on ModeX proprietary MSTAR technology. MSTAR is a flexible plug-and-play platform able to incorporate four to six independent antibody binding sites into a single molecule, dramatically expanding their therapeutic potential while enabling rapid responses to emerging infections and their viral variants, including COVID-19, influenza, and other pathogens.
The SARS-CoV-2 program is supported by HHS’ Project NextGen, which is dedicated to advancing a pipeline of innovative vaccines and therapeutics against COVID-19. The BARDA contract includes an initial $59 million for the development, manufacturing, and execution of a Phase 1 clinical trial for a next-generation MSTAR multispecific antibody with broad neutralizing activity against known variants of SARS-CoV-2. Such antibodies have the potential for both treatment and prevention of COVID-19.
This initiative builds on a collaboration between ModeX and the Vaccine Research Center of the National Institutes of Health (NIH) for the discovery and characterization of novel therapeutic antibodies against SARS-CoV-2. Additional funding of up to $109 million may be available from BARDA upon achieving particular milestones to develop multispecific antibodies targeting other viral pathogens such as influenza. As part of the research program, gene-based delivery methods for the multispecific antibodies will be developed using mRNA or DNA vectors to leverage the body’s natural protein production processes.
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